US20070162056A1 - Single fold system for tissue approximation and fixation - Google Patents
Single fold system for tissue approximation and fixation Download PDFInfo
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- US20070162056A1 US20070162056A1 US11/716,157 US71615707A US2007162056A1 US 20070162056 A1 US20070162056 A1 US 20070162056A1 US 71615707 A US71615707 A US 71615707A US 2007162056 A1 US2007162056 A1 US 2007162056A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B2017/07214—Stapler heads
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
- A61B2017/081—Tissue approximator
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2901—Details of shaft
- A61B2017/2905—Details of shaft flexible
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
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Abstract
A single fold system for tissue approximation and fixation is described herein. The devices are advanced in a minimally invasive manner within a patient's body to create at least one fold within a hollow body organ. The system comprises a tissue acquisition and folding device and a tissue stapling or fixation device, each of which is used together as a system. The acquisition device is used to approximate a single fold of tissue from within the hollow body organ and the stapling device is advanced through a main lumen defined through the acquisition device and is used to affix the tissue. The stapling device is keyed to maintain its rotational orientation relative to the acquisition device and to provide the user positional information of the stapling device. The acquisition device is also configured to provide lateral stability to the stapling device prior to the stapling device being clamped onto tissue.
Description
- The present invention relates generally to medical apparatus and methods. More particularly, it relates to devices and methods for approximating portions of a hollow body organ, particularly a stomach, intestine, or other region of the gastrointestinal tract, while affixing the tissue.
- In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to “tie off” or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.
- Typically, these stomach reduction procedures are performed surgically through an open incision and staples or sutures are applied externally to the stomach or hollow body organ. Such procedures can also be performed laparoscopically, through the use of smaller incisions, or ports, through trocars and other specialized devices. In the case of laparoscopic banding, an adjustable band is placed around the proximal section of the stomach reaching from the lesser curve of the stomach around to the greater curve, thereby creating a constriction or “waist” in a vertical manner between the esophagus and the pylorus. During a VBG, a small pouch (approximately 20 cc in volume) is constructed by forming a vertical partition from the gastroesophageal junction to midway down the lesser curvature of the stomach by externally applying staples, and optionally dividing or resecting a portion of the stomach, followed by creation of a stoma at the outlet of the partition to prevent dilation of the outlet channel and restrict intake. In a Roux-En-Y gastric bypass, the stomach is surgically divided into a smaller upper pouch connected to the esophageal inflow, and a lower portion, detached from the upper pouch but still connected to the intestinal tract for purposes of secreting digestive juices. A resected portion of the small intestine is then anastomosed using an end-to-side anastomosis to the upper pouch, thereby bypassing the majority of the intestine and reducing absorption of caloric intake and causing rapid “dumping” of highly caloric or “junk foods”.
- Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, use of general anesthesia, time and pain associated with the healing of the incisions, and other complications attendant to major surgery. In addition, these procedures are only available to a small segment of the obese population (morbid obesity, Body Mass Index≧40) due to their complications, leaving patients who are considered obese or moderately obese with few, if any, interventional options.
- In addition to surgical procedures, certain tools exist for approximating or otherwise securing tissue such as the stapling devices used in the above-described surgical procedures and others such as in the treatment of gastroesophageal reflux disease (GERD). These devices include the GIA® device (Gastrointestinal Anastomosis device manufactured by Ethicon Endosurgery, Inc. and a similar product by USSC), and certain clamping and stapling devices as described in U.S. Pat. Nos. 5,403,326; 5,571,116; 5,676,674; 5,897,562; 6,494,888; and 6,506,196 for methods and devices for fundoplication of the stomach to the esophagus for the treatment of gastroesophageal reflux disease (GERD). In addition, certain tools, such as those described in U.S. Pat. Nos. 5,788,715 and 5,947,983, detail an endoscopic suturing device that is inserted through an endoscope and placed at the site where the esophagus and the stomach meet. Vacuum is then applied to acquire the adjacent tissue, and a series of stitches are placed to create a pleat in the sphincter to reduce the backflow of acid from the stomach up through the esophagus. These devices can also be used transorally for the endoscopic treatment of esophageal varices (dilated blood vessels within the wall of the esophagus).
- There is a need for improved devices and procedures. In addition, because of the invasiveness of most of the surgeries used to treat obesity and other gastric disorders such as GERD, and the limited success of others, there remains a need for improved devices and methods for more effective, less invasive hollow organ restriction procedures.
- A system for tissue approximation and fixation is described which may be used to approximate and/or tension at least one fold of tissue from within a hollow body organ, such as the stomach, esophageal junction, and other portions of the gastrointestinal tract. Generally, the devices of the system may be advanced in a minimally invasive manner within a patient's body, e.g., transorally, endoscopically, percutaneously, etc., to create one or several divisions or plications within the hollow body organ. Examples of placing and/or creating divisions or plications may be seen in further detail in U.S. Pat. No. 6,558,400; U.S. patent application Ser. No. 10/188,547 filed Jul. 2, 2002; and U.S. patent application Ser. No. 10/417,790 filed Apr. 16, 2003, each of which is incorporated herein by reference in its entirety. The system may comprise at least a tissue acquisition and folding device and a tissue stapling or fixation device, each of which may be used together as a single system.
- The folder assembly may generally comprise, in part, a tissue acquisition assembly which may be used to initially acquire and/or approximate at least one fold of the tissue. The acquisition assembly may comprise a tensioning member and a pod member, each of which may be independently articulatable to form a first compact configuration and a second larger, expanded configuration. Each of the members may be connected to respective first and second actuation rods on the distal end of a yoke member, which connects the pod members to an elongate working body or shaft. The working body itself may be comprised of a plurality of aligned link members which are adapted to provide some flexibility to the working body and which defines a main lumen throughout a length of the working body as well as through the handle connected to a proximal end of the working body. Moreover, the working body may be covered by a sheath or a covering to enhance the lubricity of the shaft as well as to maintain the interior of the working body clear from body fluids and debris and seal the shaft to allow insufflation of the target organ. Various materials may be utilized for the sheath including various plastics, elastomers, latex, polyurethane, thermoplastics, e.g., PTFE, silicone, PVC, FEP, Tecoflex®, Pebax®, etc., so long as they are preferably biocompatible.
- At least one of the members, such as the pod member, may additionally define a vacuum chamber or opening into which the tissue may be drawn within. The opening of the vacuum chamber may be slotted along a direction parallel to a longitudinal axis of the working body; alternatively, the opening may be defined a variety of shapes, e.g., oval, elliptical, etc., and furthermore may be offset such that it is defined transverse to the longitudinal axis of the working body. The distal end of the pod member may have a flexible and/or atraumatic tip such as a blunt, rounded, or “bullet” tip, made from any number of polymers to facilitate the guidance of the acquisition assembly into the hollow body organ without damaging tissue along the way. One example of a device utilizing two pod members is described in further detail in U.S. patent application Ser. No. 10/686,326 filed Oct. 14, 2003, which is commonly owned and is incorporated herein by reference in its entirety.
- A guidewire may optionally be used with the folder assembly during initial deployment and positioning within the hollow body organ in a manner similar to a catheter for guiding the acquisition assembly to a predetermined position. The use of the guidewire may assist in initial placement of the device transorally, either through the main lumen of the device or it can also be exchanged through a lumen in the tip of the pod member. Both of the members may each be adapted to pivot on respective hinge members such that in a first compact configuration, the first and second pod members are immediately adjacent to one another. When desirably positioned within the hollow body organ, a vacuum force may be applied within a vacuum chamber defined within the pod member such that tissue enters within the vacuum chamber or opening. To assist in placement of the device, various indicators may be used. For instance, one or several indicators may be located directly on the device or indicators may be utilized with the device in relation to anatomical structures or landmarks. In one example, an orientation marker may be placed at a point on the distal portion of the device that is visible endoscopically and can be adjusted relative to structures such as the “z-line” of the gastroesophageal, i.e., the place where a change in color of the tissue from whitish (esophagus) to a salmon color (stomach) occurs delineating what is referred to as the squamocolumnar junction, i.e., the point where the lining changes from esophageal (squamous) to stomach (columnar). Then, in moving to a second expanded configuration, one or both of the tensioning member and/or the pod member may be translated via actuation rods into opposing radial directions from one another such that the tissue is drawn through the tensioning member by the pod member and approximated to create a fold of tissue. Once this tissue fold has been desirably created, the fixation assembly may be advanced distally through the main lumen of the folder assembly and positioned upon exiting the main lumen to become clamped directly over the folded tissue. It is also within the scope of this disclosure to actuate the members simultaneously, serially or singularly.
- One or more vacuum tubes may be routed through the length, or a partial length, of the working body for communication with the pod member. The proximal ends of the vacuum tubes may be connected to one or more vacuum pumps. Furthermore, the vacuum tubes may utilize braided materials, e.g., stainless steel or superelastic materials such as Nickel-Titanium alloy, integrated throughout to prevent kinking or pinching of the tubes.
- The fixation assembly comprises, in part, a manipulatable stapler assembly connected via a flexible shaft to a stapler handle. The stapler assembly itself generally comprises a staple cartridge housing within which one or more staples are housed. A corresponding anvil is positioned in apposition to the staple cartridge housing and may be used to provide a staple closure surface when tissue to be affixed is adequately positioned between the staple cartridge housing and the anvil. With the stapler assembly connected at the distal end of a flexible shaft, a handle is connected at the proximal end of the shaft. The handle itself may allow the surgeon or user to hold and manipulate the fixation assembly while articulating the stapler assembly between an open and closed configuration. Moreover, the configuration of the handle allows the surgeon or user to actuate the stapler assembly as well as deploy the staples from the staple cartridge housing.
- In use, the fixation assembly may be advanced within the folder assembly main lumen with the fixation assembly configured in a closed configuration. To maintain an orientation, i.e., rotational stability, of the fixation assembly relative to the folder assembly and the approximated tissue, the fixation assembly may be configured to have a shape which is keyed to a cross-sectional area of the folder assembly main lumen. The keyed configuration helps to ensure that as the fixation assembly is advanced through the folder assembly, that the stapler assembly is optimally positioned to be clamped over the tissue for fixation.
- When the stapler assembly is advanced and has exited the main lumen of the working body, the staple cartridge housing may be actuated into an open configuration when positioned between distally extending arm members of a yoke to receive the tissue folded between the pod members. The yoke arm members are configured such that when the stapler assembly is positioned therebetween, the stapler assembly is prevented from rotating or bending out of alignment for tissue affixation, i.e., the lateral stability of the stapler assembly is maintained relative to the yoke and the tissue. The stapler assembly may then be advanced distally over the folded tissue and clamped onto the tissue for deploying the staples. To avoid damaging tissue surrounding the acquisition assembly, one or several insertion indicators may be defined along a portion of flexible shaft of the fixation assembly, preferably near a proximal end of the shaft, to aid the user in knowing when the stapler assembly may be safely articulated while the fixation assembly is positioned within the working body, i.e., the longitudinal stability of the stapler assembly is maintained relative to the folder assembly. The indicators may be configured to align with a proximal end of the folder handle to correspondingly indicate, e.g., a position of the fixation assembly relative to the folder assembly when the stapler assembly may be opened, and/or how far distally the fixation assembly may be advanced relative to the folder assembly to engage the folded tissue, and when the devices are in a “safe to clamp” mode (e.g., in position around the tissue). Such positional indicators may utilize mechanical features, such as a stop or detent. In addition, the stapler assembly jaws my be spring-loaded open to assist insertion.
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FIG. 1 shows a perspective view of a tissue folding and fixation assembly which may be advanced within a hollow body organ to reconfigure the tissue from within. -
FIGS. 2A and 2B show open and closed perspective views, respectively, of the tissue folding assembly, respectively, which may be used to manipulate tissue. -
FIG. 3 shows a perspective view of one variation of the tissue folding assembly in which a guidewire may be used to facilitate deployment and/or placement within a body. -
FIGS. 4A and 4B show side views of a variation of the tissue folding assembly in an open and closed configuration, respectively, where the members may be configured to maintain a parallel configuration relative to one another. -
FIGS. 5A and 5B show open and closed perspective views, respectively, of another variation of the tissue folding assembly showing an attachment region. -
FIG. 6 shows an end view of a closed tissue folding assembly. -
FIG. 7 shows a perspective view illustrating in one variation how a stapler assembly may be advanced through the main lumen of the working body. -
FIGS. 8A to 8C show cross-sectional side views of rotatable valves which may be used control the vacuum force within the device. -
FIGS. 9A and 9B show an end view of an acquisition assembly which has been translated with respect to one another while adhering tissue. -
FIG. 10A shows a partial assembly of the handle for the folder assembly. -
FIG. 10B shows a detail view of an exploded assembly of anchoring mounts and a proximal portion of an actuation rod assembly. -
FIG. 11 shows a side view of an alternative variation on a dual actuator folder assembly housing. -
FIGS. 12A to 12C show side, end, and perspective views, respectively, of a link which may serve as a transitional link between the folder handle and the working body. -
FIGS. 13A to 13C show side, end, and perspective views, respectively, of one variation of links which may be used to form at least part of the working body. -
FIG. 13D shows an end view of a link having cross-sections of some of the various internal lumens which may be routed through the working body. -
FIGS. 14A to 14C show side, end, and perspective views, respectively, of one variation of an end link which may be used as a terminal link of the working body. -
FIG. 15 shows an end view of a link with the fixation assembly positioned within for advancement through the main lumen of the working body while maintaining a consistent orientation. -
FIGS. 16A to 16C show top, cross-sectional side, and perspective views, respectively, of one variation of a yoke member. -
FIGS. 17A and 17B show front and rear end views, respectively, of the yoke member ofFIGS. 16A to 16C. -
FIG. 18 shows a top view of a stapler cartridge assembly positioned between the arm members of the yoke. -
FIGS. 19A and 19B show variations of the stapler assembly positioned between the yoke having varied open regions. -
FIGS. 20A to 20C show top, end, and side views, respectively, of an alternative angled hinge member for use with a tensioning and/or pod member. -
FIGS. 21A to 21C show top and perspective views, respectively, of a variation of a yoke and hinge assembly. -
FIG. 22A shows a perspective view of one variation of a top cover which may be used with the acquisition assembly. -
FIG. 22B shows a cross-sectional view of an optional basket insert positioned within a vacuum chamber and a top cover secured over the chamber. -
FIGS. 23A and 23B show another variation ofFIGS. 22A and 22B , respectively, where the top cover and/or pod member may have serrations. -
FIGS. 24A to 24D show side, end, bottom, and perspective views, respectively, of an optional basket insert which may be placed within the vacuum chamber of the pod assembly. -
FIGS. 25A and 25B show side views of a variation of the stapler assembly in clamped and opened configurations, respectively. -
FIGS. 26A and 26B show side views of a variation of a cam member which may be used to urge the stapler assembly open and close. -
FIGS. 27A to 27C show cross-sectional side, front, and top views, respectively, of one variation of stapler assembly. -
FIG. 27D shows a top view of the anvil of the stapler assembly. -
FIG. 28 shows a side view of another variation of a stapler assembly having serrations defined along its clamping surfaces. -
FIG. 29A shows a top view of one variation of staple pushers positioned over corresponding staples. -
FIG. 29B shows a detailed perspective view of one example of a staple pusher. -
FIG. 29C shows a perspective view of one example of a wedge which may be configured to slide within the cartridge housing. -
FIGS. 30A and 30B show cross-sectional side views of one variation of a stapler handle and its associated controls. -
FIGS. 31A and 31B show perspective views of another variation of the approximation device having an actively or passively curved working body. -
FIG. 31C shows a detail view of the actuation handle of the device inFIGS. 31A and 31B . -
FIGS. 32A and 32B show perspective and end views, respectively, of a variation of an end cap or seal which may be used to cap the handle ofFIG. 31C . -
FIG. 33 shows a perspective view of one variation in which an endoscope can be retroflexed to view the results or progress of the tissue approximation and/or fixation. -
FIG. 34 shows a portion of a flexible shaft of a stapler assembly with several insertion indicators positioned through the main lumen of the handle of the folder assembly. - A system for tissue approximation and fixation is described which may be utilized for approximating tissue regions from within a hollow body organ, such as the stomach, esophageal junction, and other portions of the gastrointestinal tract. The system may be advanced within a body through a variety of methods, e.g., transorally, transanally, endoscopically, percutaneously, etc., to create one or several divisions or plications within the hollow body organ. At least two devices may be utilized as part of the system, a tissue acquisition and folding system and a tissue stapling or fixation system, although it is contemplated that both devices can be integrated into a single mechanism. Each of these devices may be configured to efficiently operate with one another to provide optimal methods and devices for at least acquiring, approximating, and stapling regions of tissue from within the hollow body organ in a minimally invasive manner.
- Turning now to the figures, the system will first be described generally in which one variation of system 10 is shown in
FIG. 1 , which illustrates a perspective view of folder assembly 12 andfixation assembly 14. This system may be particularly useful in creating and approximating at least a single fold of tissue from within the hollow body organ. Such treatments may be effectuated for a variety of maladies; one particular malady in which such a system may be used is for the treatment of GERD. Folder assembly 12, which is described below in greater detail, may be comprised generally ofacquisition assembly 16, which may be used to initially acquire and approximate the tissue to be folded.Acquisition assembly 16 may have a tensioningmember 18 and apod member 20, each of which may be independently articulatable to form a first compact configuration and a second larger, expanded configuration. Each of tensioningmember 18 andpod member 20 may be connected to respective first andsecond actuation rods yoke member 26, as described in further detail below. -
Acquisition assembly 16 may be located at the distal end of workingbody 28 which may be configured as a flexible shaft having one or several lumens defined through the length of the workingbody 28. The workingbody 28 may be covered by a sheath or covering 30 to enhance the lubricity of the shaft as well as to maintain the interior of thebody 28 clear from body fluids and debris and provide a seal to allow insufflation of the target organ. Various materials may be utilized forsheath 30 including various plastics, elastomers, latex, polyurethane, thermoplastics, e.g., PTFE, FEP, silicone, PVC, Tecoflex®, Pebax®, etc., so long as they are preferably biocompatible. - A number of
vacuum tubes 32 may also be routed through the length, or a partial length, of the workingbody 28 toacquisition assembly 16. The figure showsvacuum tubes 32 entering the workingbody 28 at its proximal end. Alternatively,vacuum tubes 32 may enter workingbody 28 at some distal point along the length ofbody 28 orvacuum tubes 32 may enter workingbody 28 throughhandle 34. In either case,vacuum tubes 32 may be positioned within one or several lumens defined through workingbody 28 and placed in fluid communication withpod member 20 to facilitate in vacuum actuation of tissue, as further described below. The proximal ends ofvacuum tubes 32 may be connected to one or more vacuum pumps (not shown). Furthermore,vacuum tubes 32 may utilize braided materials, e.g., stainless steel, superelastic materials such as Nickel-Titanium alloy, integrated throughout to prevent kinking or pinching of thetubes 32.Such vacuum tubes 32 may also accommodate insertion of a snare or grasper type device that can be inserted once tissue is acquired to mechanically grasp the invaginated tissue, depending on the type of tissue manipulation desired. An example of a “gooseneck” snare by Microvena, Inc. which may be used with thevacuum tubes 32 is described in further detail in U.S. Pat. No. 5,171,233, which is incorporated herein by reference in its entirety. - The proximal end of working
body 28 is operatively connected to handle 34. Also connected to handle 34 are first andsecond actuators member 18 andpod member 20 from the first compact configuration to the second larger, expanded configuration. Eachactuator Main lumen 40 may be defined throughout the length of workingbody 28 and throughhandle 34 such thatfixation assembly 14 may be advanced and withdrawn through the folder assembly 12.Fixation assembly 14 comprises, in part,stapler assembly 42 connected viaflexible shaft 48 to astapler handle 50.Stapler assembly 42 generally comprisesstaple cartridge 44, within which one or more staples are housed.Stapler assembly 42 may also have an optional tapered distal end to facilitate insertion of the device into or past tissue, as described in further detail below. Anvil 46 is in apposition tostaple cartridge 44 and is used to provide a staple closure surface when tissue to be affixed is adequately positioned betweenstaple cartridge 44 and anvil 46. Withstapler assembly 42 connected at the distal end offlexible shaft 48, handle 50 is connected at the proximal end ofshaft 48.Handle 50 may generally comprise a housing andgrip 52 in apposition to actuation handle 54.Handle 50 allows for the surgeon or user to hold and manipulatefixation assembly 14 withgrip 52 while articulatingstapler assembly 42 between an open and close configuration viaactuation handle 54. Moreover, the configuration ofhandle 50 allows the surgeon or user to articulatestapler assembly 42. - When
fixation assembly 14 is advanced within folder assembly 12,stapler assembly 42 is preferably in a closed configuration. Whenstapler assembly 42 has exited workingbody 28,staple cartridge 44 may be articulated into an open configuration when positioned betweenyoke 26 to receive the tissue folded between tensioningmember 18 andpod member 20.Stapler assembly 42 may then be advanced distally over the folded tissue and clamped close over the tissue for deploying the staples. To avoid damaging tissue surroundingacquisition assembly 16 and to facilitate proper stapling, one or several insertion indicator(s) 56 may be defined along a portion offlexible shaft 48 preferably near a proximal end ofshaft 48, to aid the user in knowing whenstapler assembly 42 may be safely articulated whilefixation assembly 14 is positioned within workingbody 28. Indicators 56 may be configured to align with a proximal end of folder handle 34 to correspondingly indicate, e.g., a position offixation assembly 14 relative to folder assembly 10 whenstapler assembly 42 may be opened, and/or how far distallyfixation assembly 14 may be advanced relative to folder assembly 10 to engage the folded tissue, etc. In addition to visual indicators, a mechanical indication, such as a stop or detent may be employed to give the operator a tactile indication of “safe to open” and “safe to clamp” device positions. - A brief description of the
acquisition assembly 16 will be given in order to describe how the tissue may be manipulated by the devices described herein. A more detailed description will be given below. Perspective views of one variation ofacquisition assembly 16 in an open and closed configuration are shown inFIGS. 2A and 2B , respectively. Tensioningmember 18 may be comprised of tensioningarms tensioning arm arms arms - The
pod member 20 may be comprised of a vacuum chamber or opening 60 into which tissue may be drawn therewithin. Avacuum tube 76, as may be seen inFIG. 4A , leads topod member 20. The opening ofvacuum chamber 60 may be slotted along a direction parallel to a longitudinal axis of the workingbody 28, or may be transverse to the parallel axis; alternatively, the opening may be defined a variety of shapes, e.g., oval, elliptical, etc. One or both tensioningarms vacuum chamber 60 and may have a length equal to that ofvacuum chamber 60. Alternatively, the lengths of tensioningarms vacuum chamber 60. The distal end of thepod member 20 may have a flexible and/oratraumatic tip 66 made from any number of polymers to facilitate the guidance ofacquisition assembly 16 into the hollow body organ without damaging tissue along the way. The tensioningarms arms arms - In its compact configuration, tensioning
member 18 andpod member 20 ofacquisition assembly 16 may each be shaped to compactly fit with one another. For instance, in this variation, tensioningarms vacuum chamber 60. In alternative variations, tensioningarms arms - When tensioning
member 18 andpod member 20 are actuated between an open configuration, as shown inFIG. 2A , and closed configuration, as shown inFIG. 2B , each of themembers member 18 andpod member 20 may each be adapted to pivot onrespective hinge members member 18 andpod member 20 may be immediately adjacent to one another. In moving to a second expanded configuration, tensioningmember 18 with tensioningarms pod member 20 may be translated viaactuation rods yoke 26, as shown inFIG. 2A . With tensioningmember 18 andpod member 20 in the open configuration, atissue fixation region 92 may be defined between themembers FIGS. 4A and 4B show side views of an open and closed configuration, respectively, of the variation in whichmembers FIG. 4A showsmembers tissue fixation region 92 between the members, which are shown in this variation as being parallel to one another.FIG. 4B showsmembers members - A guidewire may optionally be used with the folder assembly 12 during initial deployment and positioning within the hollow body organ in a manner similar to a catheter for guiding
acquisition assembly 16 to a predetermined position. Accordingly, an optional guidewire lumen may be defined inatraumatic tip 66. As seen inFIG. 3 ,guidewire lumen 68 may be defined throughatraumatic tip 66 withguidewire 80 extending through from guidewire opening 70 to guidewire opening 78. Guidewire openings 70, 78 may both be defined on, e.g.,atraumatic tip 66, to enable exchange of the guidewire through one or both tips; however, guidewire openings 70, 78 may also be defined on other regions ofpod member 20 depending upon the type of exchange capability desired. -
FIGS. 5A and 5B show tensioningmember 18 andpod member 20 actuated between an open configuration and closed configuration, respectively, with theatraumatic tip 66 removed. Theattachment region 94 may be used during deployment without any attachments upon theregion 94. Alternatively, various other devices aside from anatraumatic tip 66 may be utilized for attachment toregion 94. For example, components for use in drug delivery, dye marking, sensors for detecting various physical parameters, etc., may be utilized and attached ontoregion 94. -
FIG. 6 shows an end view of theacquisition assembly 16 in a closed configuration. As seen in this particular variation, tensioningarms vacuum chamber 60 to form a compact configuration for delivery. Tensioningarms vacuum chamber 60, however, tensioningarms -
FIG. 7 shows a perspective view illustrating in one example howstapler assembly 42 may be advanced through themain lumen 40 of workingbody 28. Once tensioningmember 18 andpod member 20 have been actuated into an open configuration (the approximated tissue is not shown for clarity),stapler assembly 42 may be advanced distally and manipulated such thatstaple cartridge 44, within which one or more staples are housed, and anvil 46 are in an open configuration ready to clamp over and fasten any approximated tissue which may be presented between tensioningmember 18 andpod member 20 infixation region 92. - The vacuum force which may be used to draw in the tissue within
vacuum chamber 60 ofpod member 20 may be controlled through a number of various methods. One variation is illustrated inFIGS. 8A to 8C, which show howvalves 82 may be integrated intohandle 34 for controlling the vacuum force. As seen in the cross-sectional side view ofFIG. 8A ,valve 82 may be configured to rotate and align such thatvacuum lumen 84 comes into fluid communication withlumen 86, which leads to workingbody 28.Vacuum lumen 84 may be connected to a vacuum control unit (not shown), e.g., a standard luer assembly (QOSINA, model # 99720), to allow for air to be drawn throughlumen 86 and create the vacuum at the distally-located pod members.FIG. 8B shows howvalve 82 may be rotated by some degree, e.g., 45° relative to a longitudinal axis ofhandle 34, such that the vacuum force is no longer in fluid communication withlumen 86.FIG. 8C shows howvalve 82 may be further rotated, e.g., 90° relative to a longitudinal axis ofhandle 34, such thatlumen 86 is in fluid communication withventing lumen 88 to allow for venting of the assembly. A second valve, as shown, may be integrated inhandle 34 to allow for the independent control of the vacuum force in a second optional pod member.Vacuum lumen 84 may be fluidly connected to a common or independent vacuum pump. Moreover, rather than having two independentlycontrollable valves 82, asingle valve 82 may be utilized to control the vacuum force in thepod member 20, depending upon the desired results. The above variations are intended to be illustrative and are not intended to be limiting in their scope of the disclosure in the various possible configurations and methods available for controlling the vacuum force. -
FIGS. 9A and 9B show the movement of tensioningmember 18 andpod member 20 relative to one another in reconfiguring the surrounding tissue.FIG. 9A shows an end view of tensioningmember 18 andpod member 20 which have been advanced while in a closed configuration into, e.g., a stomach, and positioned adjacent to a region of interior tissue to be reconfigured. When desirably positioned, a vacuum force may be applied withinvacuum chamber 60 ofpod member 20 such that tissue enters within the vacuum chamber oropening 60. - The different linings of the stomach, which include the mucosal layer MUC, muscular layer ML, and serosal layer SL, are shown in cross-section. The vacuum force may be applied such that at least the mucosal layer MUC of the tissue, e.g., an anterior wall AW and posterior wall PW, is drawn into
vacuum chamber 60 and the tissue is sufficiently adhered to thepod member 20. While the vacuum force is applied, tensioningmember 18 andpod member 20 may be translated away from one another in opposing direction such that the adhered tissue is drawn between the tensioningarms member 18 andpod member 20 such that at least two adjacent folds of tissue are created to form an overlap region of tissue, as shown inFIG. 9B . Alternatively, rather than having both tensioningmember 18 andpod member 20 move opposite to one another simultaneously, one member may be held stationary while the other member is translated radially. In another alternative,pod member 20 may acquire the tissue and tensioningmember 18 may be first translated and thenpod member 20 may be subsequently translated as a separate step to enhance tissue acquisition and positioning. After the tissue has been acquired through any of the methods described above, the device may be curved or manipulated, as described in further detail below. The tissue may then be affixed through one of the methods as described herein. - The methods described herein in acquiring a single, longitudinal fold, may be particularly effective for use in treatments such as GERD or to exclude certain portions of the wall of the body organ. In addition, the device can assist in the placement or revision (e.g. as a secondary operation or secondary step in a single procedure) of certain surgical procedures, such as a Roux En Y gastric bypass, or vertical banded gastroplasty, or other restrictive procedures where the resulting pouch may be stretched over time and may need further reduction. Further, certain procedures can lead to unforeseen results such as the formation of a gastric/gastric fistula. Such a fistula may be closed with the devices and methods described herein. In a further example, the efficacy of the placement of a series of sutures or staples to form what is typically referred to as a “Collis” procedure, may be enhanced by the addition of a tissue fold at the outlet of the “Collis” geometry, in the vicinity of the pylorus, or at any point along the resulting geometry to create resistance to food intake or enhance food dwell time in the gastric region. Examples of other treatments are described in further detail in co-pending U.S. patent application Ser. No. 10/417,790, which has been incorporated by reference above. When the single tissue overlap is created by folder assembly 12, the overlap preferably includes an overlap of at least the muscular layer ML and serosal layer SL to ensure a secure anchoring platform for the staples or fasteners to maintain the durability of the tissue overlap. Such an overlap can also serve as a way for securing an additional item within the organ such as pacing leads, sensors (e.g. monitoring of stretch receptors within the stomach), monitors, or other such diagnostic or therapeutic devices, including but not limited to those described in U.S. patent application Ser. No. 10/215,070 filed Aug. 7, 2002, which is incorporated herein by reference in its entirety. A more detailed discussion may be found in U.S. patent application Ser. No. 10/188,547 filed Jul. 2, 2002, which is incorporated herein by reference in its entirety.
- Folder Assembly
- Folder assembly 12 may typically comprise a
handle 34 at a proximal end of the assembly 12, as described above.Handle 34 may comprisehousing 110 which may enclose a pod actuation assembly within.FIG. 10A shows a partial assembly ofhandle 34 to illustrate the internal mechanisms. As described above,first actuator 36 may be used to manipulate tensioningmember 18 from a first configuration to a second configuration. Manipulation may be achieved, in part, by havingfirst actuator 36 connected viashaft 112 to transmit a torquing force to threadedcarriage shaft 114. Thecarriage shaft 114 is preferably free-floating, i.e., can translate longitudinally inside theshaft 112.Proximal mount 116 may be free to rotate about thecarriage shaft 114, but it is preferably constrained to inhibit translation ofmount 116 relative to thecarriage shaft 114.Distal mount 118 may be slidingly positioned overcarriage shaft 114, typically by a threaded connection. This threaded connection maintains a fixed relative distance between the mounts so that the mounts and thecarriage shaft 114 may translate longitudinally as a unit.Proximal mount 116 anddistal mount 118 may be anchored to the proximal ends of the actuation rod and tubing member, which houses the actuation rod, as described further below. Eachmount shaft 112 may be configured to be free-floating, i.e., translate longitudinally unconstrained, inside ofshaft 112 withinfirst actuation channel 120 to accommodate the lateral movement of workingbody 28 and the subsequent translational movement of the proximal ends of actuation rods withinhousing 110. Stop 144, e.g., a ring or shoulder defined uponshaft 114, may be positioned proximally ofmount 116 to prevent the longitudinal movement ofmount 116 alongshaft 114.Mounts second actuation channel 122 for a second actuation rod.Mounts actuator 36 is rotated. - The
handle mechanism 34 helps to ensure that relative or unwanted movement of the pods during flexing of the shaft of the folder in minimized or eliminated. Additionally,tubes 136, as further described below, function so that the shaft of the device is not loaded during actuation. Thesetubes 136 help to support the actuation load, but still allow sufficient shaft flexibility. - As shown in
FIG. 10B , which is a detail view of an exploded assembly ofmounts Proximal mount 116 may have arod anchoring region 130 defined along one side anddistal mount 118 may havetubing anchoring region 132 defined along one side and collinearly withrod anchoring region 130.Actuation rod 140 may be slidingly positioned withintubing member 136 and configured to slide longitudinally therewithin when translated relative totubing member 136 for actuating a pod member.Actuation rod 140 may be anchored toproximal mount 116 by securely positioningactuation rod anchor 142 within anchoringregion 130. Likewise,tubing member 136 may be anchored todistal mount 118 by positioningtubing anchor 138 withintubing anchoring region 132. Eachmount openings 134 to accommodaterod tubing 136 andactuation rod 140 when they are secured within anchoringregions actuator 36 is rotated,carriage shaft 114 is rotated about its longitudinal axis to urgemount 118 towards or away frommount 116, as shown by the arrows, depending upon whichdirection carriage shaft 114 is rotated. When mounts 116, 118 are urged towards one another,actuation rod 140 is forced to slide distally within and relative totubing 136 to urge the pod member, e.g., into its expanded configuration. Similarly, when mounts 116, 118 are urged away from one another,actuation rod 140 is forced to slide proximally within and relative totubing 136 to urge the pod member, e.g., into its compact configuration. - As further seen in
FIG. 10A ,main lumen 40 may be defined through a length ofhousing 110 to accommodate insertion of thefixation assembly 14 therethrough. Theproximal opening 128 oflumen 40 may be gasketed to allow for the insufflation of the hollow body organ using the device as well as to prevent the leakage of bodily fluids and particles.Distal opening 124 may likewise be gasketed and is further configured to accept a proximal end of workingbody 28. Theindividual links 126 of one variation of the proximal end of workingbody 28 are shown in the figure to illustrate an example of the mating between workingbody 28 andhousing 110. - An alternative variation on the folder assembly housing is shown in
dual actuator assembly 150 inFIG. 11 . In this variation, a side view ofhousing 152 is seen in which a single actuator or lever 158 may be utilized to manipulate both tensioningmember 18 andpod member 20 simultaneously. Lever 158 may be configured to rotate aboutpivot 160 to urgeactuation link 162 to translate withinactuation slot 164 to simultaneously manipulate both members rather than having two or more separate controls. The proximal end of workingbody 154 may be seen connected tohousing 152 andvacuum tube 156 may be seen leading into workingbody 154 for communication with the folder assembly. - When lever 158 is depressed,
actuation link 162 translatesproximal linkage 155 withinactuation slot 164.Proximal linkage 155 is free to rotate about a pivot during flexure of the workingbody 154 and actuatesproximal blocks 153 to slide longitudinally withinchannels 151, which are defined throughhousing 152. A spring or biased element 168 may be positioned withinslot 164 to place a biasing force onlink 162 and lever 158 such that the assembly maintains a neutral or fixed orientation, if desired.Proximal blocks 153 are connected to actuationrods 157 which may extend distally throughdistal blocks 159 and further into workingbody 154.Distal blocks 159 may be pivotally connected todistal linkage 163, which may be pivotally affixed tohousing 152 via pivot 166 while allowingdistal blocks 159 to translate withinchannels 151.Tubing members 161 may be configured to allow passage ofactuation rods 157 therethrough while remaining connected todistal blocks 159. Although the specific configuration of this variation is shown and described, this is not intended to be limiting and is illustrative of one variation of a handle which allows for single activation and tunable mechanical advantage. - The working
body 28, which extends between the handle and the pod assembly located at the distal end of the workingbody 28, may be comprised of a plurality of links or knuckles generally cylindrical in shape and positioned adjacently to one another, as shown and described above inFIG. 10A . A transition link orknuckle 170 is shown inFIGS. 12A to 12C, which show side, end, and perspective views, respectively, of a link which may serve as a transitional link between the handle and the length of the workingbody 28. As seen in the side view ofFIG. 12A ,transition link 170 may have a proximally located cylindrically-shapedflange 172 with a diameter greater than a diameter of thebody portion 176.Flange 172 may serve to help anchor the workingbody 28 to the handle by fitting within a cavity defined in the handle and shaped to receiveflange 172. Atransition portion 174 may taper a region of thelink 170 down tobody portion 176. The end view inFIG. 12B showsmain lumen 178 defined through the length oflink 170.Main lumen 178 may be shaped with parallel sides opposite to one another to allow fixation assembly therethrough in a specified configuration, as described below in further detail. - Although the
transition link 170 is shown to be generally cylindrical in shape, it may alternatively be configured in a variety of shapes, e.g., ovular, elliptical, etc.Transition link 170 may also range in diameter, e.g., 0.75 in. (about 1.90 cm), so long as it is wide enough to accommodate the insertion offixation assembly 14 therethrough yet small enough to be inserted into the body, e.g., through the esophagus.Link 170 may also range in length, e.g., 1.125 in. (about 2.85 cm), depending upon the desired design characteristics. Moreover,transition link 170 may be made from a variety of materials, e.g., metals, plastics, etc., so long as it is biocompatible. For example,transition link 170 may be made from stainless steel, nickel-titanium alloys, or it may be molded from plastics and thermoplastics, e.g., polycarbonate resins such as Makrolon® (Bayer Aktiengesellschaft, Germany). -
FIGS. 13A to 13C show side, end, and perspective views, respectively, of an example of a knuckle or link 180 which may be used to form at least part of the workingbody 28. Thislink variation 180 may be made from a material similar to that oftransition link 170. It may also range in diameter, e.g., 0.69 in. (about 1.75 cm), so long aslink 180 is wide enough to accommodate the insertion offixation assembly 14 therethrough yet small enough to be inserted into the body, as above.Lumen 182 may be configured such that it is keyed to allowfixation assembly 14 to pass through in a specified configuration; thus, in this particular variation,lumen 182 is shown as havingstraight walls 196, which may be parallel and opposite to one another.Link 180 may also define one ormore routing channels 184 around the circumference of thelink 180 to allow for the routing of various wires or tubes therethrough along a length of workingbody 28.Link 180 shows a variation in which tworouting channels 184 may be defined on opposing sides around the circumference. As further seen inFIG. 13A , link 180 may further define peripherally locatedactuator rod lumens 196 andadditional routing lumens 188 inlink 180 outside oflumen 182. This variation shows at least two of eachlumen link 180, although they may be defined elsewhere around link 180 in other variations depending upon the number of lumens desired as well as spacing considerations. -
FIG. 13B shows a side view oflink 180 having least twoprotrusions 190 extending from afirst surface 192 on either side of the periphery oflink 180.Protrusions 190 may extend fromfirst surface 192 at a distance, e.g., 0.040 in. (about 0.10 cm), so that when multiple links are aligned with one another,protrusions 190 abut thesecond surface 194 of an adjacent link, as shown inFIG. 13C . When multiple links are aligned,lumen 182, as well asactuator rod lumen 186 andadditional routing lumen 188 may be aligned with adjacent links to form the overallmain lumen 40 and actuator rod lumen, as described above. Alternatively, overall flexibility of the device may be achieved by a single structure that contains axial slots along its length, such as that shown in U.S. Pat. No. 5,685,868, which is incorporated herein by reference in its entirety. Similarly, the working body may be formed of a single piece, flexible component, such as a polymer extrusion and/or multi-lumen co-extruded design, a braid, or other such known materials. -
FIG. 13D shows an end view oflink 180 in one variation whereactuation rod 198 is routed throughactuator tubing member 202 and both may be disposed withinactuator rod lumen 186 such that both extend through a length of workingbody 28.Vacuum tubes 200 may also be positioned within routingchannels 184 and the entire assembly may be covered by sheath or lining 204, which may extend along at least a portion of workingbody 28, and preferably over the entire length of workingbody 28. If asingle pod member 20 having avacuum chamber 60 is utilized, one of the twovacuum tubes 200 may be utilized. Alternatively, asecond vacuum tube 200 may also be utilized if the tensioningmember 18 were configured with openings for allowing a vacuum to be created therethrough or if a second pod member were utilized. Sheath or lining 204, as mentioned above, may be used to enhance the lubricity of the workingbody 28 as well as to maintain the interior of thebody 28 clear from body fluids and debris and to provide sealing to enable insufflation of the target area. Various materials may be utilized forsheath 204 including various plastics, elastomers, latex, polyurethane, thermoplastics, e.g., PTFE, silicone, PVC, FEP, Tecoflex®, Pebax®, etc., so long as they are preferably biocompatible. Moreover,sheath 204 may also utilize braided materials integrated throughout to increase tensile, compressive, and/or torsional strengths ofsheath 204 as well as to provide for resistance against kinking or pinching between individual links or when workingbody 28 is flexed. -
FIGS. 14A to 14C show side, end, and perspective views, respectively, of one variation ofend link 210, which may be utilized as the terminal or final link of workingbody 28.End link 210, much likelinks 180, may define akeyed lumen 212, routinglumens 214, andactuator rod lumen 218.Lumen 216 may also be defined and it may be counterbored to accommodate a mechanical fastener for connecting the yoke member. As the terminal link,actuator tubing member 202 may be terminated and attached to end link 210 atlumen 218 while allowing the actuator rod to extend through and beyondlumen 218 for attachment to the pod assembly. Side and perspective views inFIGS. 14B and 14C further show detent 222, which may be defined along the end surface oflink 210 for receiving and/or engaging the yoke member. Moreover, end link 210 may be made from the same or similar materials as described above for the other links. However,end link 210 is preferably made from a material such as a metal, e.g., stainless steel, or polycarbonate, which may withstand forces generated during pod and tissue manipulation. Theend link 210, or a similar or additional link, may also be used to terminate any covering placed over the workingbody 28 as heretofore described inFIG. 13D . -
FIG. 15 shows an end view oflink 180 withstaple cartridge 44 and anvil 46 offixation assembly 14 positioned withinlumen 182 for advancement through workingbody 28. As seen,lumen 182 may be configured such that it is keyed to allowfixation assembly 14 to pass through in a specified orientation.Walls 196, which may be parallel and opposite to one another, may thus be sized and configured to preventfixation assembly 14 from rotating about its own longitudinal axis withinlumen 182 during advancement and deployment from the main lumen. Maintainingfixation assembly 14 in a predetermined orientation relative to workingbody 28 andpod assembly 16 also helps to ensure that whenstaple cartridge 44 and/or anvil 46 are actuated to open for clamping over folded tissue, a known orientation offixation assembly 14 relative to the folded tissue is maintained for tissue fixation. Other configurations for keyinglumen 182 tofixation assembly 14 may be available in other variations; the shape oflumen 182 and the cross-sectional shape offixation assembly 14 are not intended to be limiting but are merely illustrative of one possibility of creating and/or configuring a keyed orientation between the two assemblies. - A yoke member may be positioned at the terminal end of working
body 28 for holding and maintainingpod assembly 16.FIGS. 16A to 16C show top, cross-sectional side, and perspective views, respectively, ofyoke 230. Generally,yoke 230 may be comprised offirst arm member 232 andsecond arm member 234 extending in parallel to one another from abase member 242, which may be attached viaproximal surface 244 to end link 210 of workingbody 28.Yoke 230 may terminate at eacharm member second pivot regions pod assembly 16 may be manipulated. First andsecond arm members open region 240 between thearm members second arm members yoke 230 within a tissue region. The opposing sides of eacharm member open region 240, may be parallel to one another and are spaced apart, e.g., at 0.40 in. (about 1.0 cm), to provide clearance forstapler assembly 42 to be advanced therethrough. Furthermore, the open sides ofregion 240 may provide adequate clearance forstapler assembly 42 to be opened for advancement over tissue to be affixed whilearm members stapler assembly 42 relative toyoke 230 and workingbody 28. - The actuation rods for manipulating
acquisition assembly 16 may extend throughyoke 230 via first and secondactuation rod channels yoke 230 inFIG. 16C . A portion ofactuation rod channels arm members FIGS. 17A and 17B show front and rear end views, respectively, ofyoke 230 to provide a detail view ofactuation rod channels open region 240. - As mentioned above and as shown in the top view of stapler cartridge/yoke assembly 250 in
FIG. 18 , eacharm member stapler assembly 42 to be advanced therethrough. Thearm members stapler assembly 42 oriented in a predetermined configuration relative toyoke 230. Furthermore,open region 240 may provide adequate clearance forstapler assembly 42 to be opened prior to advancement over tissue while guide surfaces 252, 254 help to maintain the orientation ofstapler assembly 42 relative toyoke 230 and workingbody 28. Additionally, as shown inFIG. 18 , clearance slots (open region 240) may function to provide clearance for an endoscope or other tool, that can be inserted and advanced or retroflexed to view the working device, as shown below in further detail. - To assist in alignment of the
stapler assembly 42 to the target tissue, it may be desirable to vary the length of theopen region 240. As further shown inFIG. 19A ,open region 240 may be configured with a stop, cover, orextension 256 located adjacent toanvil 253 to constrain any transverse or lateral movement ofanvil 253 while facilitating movement ofcartridge assembly 251. Alternatively, ifanvil 253′ is configured to move, stop orextension 258 may be configured adjacent tocartridge assembly 251′ to constrain any transverse or lateral movement ofcartridge assembly 251′ while facilitating movement ofanvil 253′, as shown inFIG. 19B . - From the distal end of each
arm member yoke member 230, a hinge member may be connected pivotally and extend distally where it may be again pivotally connected to a pod member. An alternativeangled hinge member 260 may be seen inFIGS. 20A to 20C, which show top, end, and side views, respectively.Angled hinge 260 may have aproximal portion 262 connected to adistal portion 264, which may be angled with respect to either or bothside surface 270 andtop surface 272 ofproximal portion 262. A yoke-hinge pivot 266 may be defined at a proximal end ofproximal portion 262 for pivotal connection tofirst pivot 236 located onyoke 230. Similarly, a hinge-pod pivot 268 may be defined at a distal end ofdistal portion 264 for pivotal connection to a pod member. Additionally,actuator rod channel 274 may be optionally defined along at least a portion ofproximal portion 262 to provide an opening or space for placement of an actuator rod. A second hinge member, which may mirror the configuration ofangled hinge 260, may be configured for connection tosecond hinge 238 ofyoke 230 for connection to tensioningmember 18. Moreover, angledhinge member 260 may be made from any variety of metals or thermoplastics, as described above. - Alternatively, a variation of a yoke/
hinge assembly 280 may be utilized, as shown in the top views ofFIGS. 21A and 21B . In this variation, yoke/hinge assembly 280 may be configured to flex via one or several additional pivots along its length.Additional ramp members yoke 282 having pivoted regions at both proximal and distal ends, may be joined viapivots Hinge members pivots members pivots member 18 andpod member 20. -
Hinge members FIG. 21A , and yoke/hinge assembly 280 may also be configured to flex via tensioning members (not shown) positioned within a lumen or slot defined along the length ofassembly 280 in one or both arms. These tensioning members may be actively manipulated by the user from their proximal ends. Thus,assembly 280 may be flexed to have a bend radius, as shown in the example ofFIG. 21B , to allow access to various regions within the hollow body organ as well as to affix various configurations of tissue. Alternatively,assembly 280 may also be passively flexed by contact against tissue or via an external device, such as a mandrel, a gripping tool, or endoscopes configured to flex theassembly 280.FIG. 21C shows an example of a compact configuration ofassembly 280 which may be utilized for deployment within a body. - In another variation, the folder assembly 12 may include a hinge device adapted to actively angle the
acquisition assembly 16 in an offset configuration. For example, theacquisition assembly 16 may be actuated to rotate the tensioningmember 18 andpod member 20 about respective pivots such that themembers body 28. From this offset configuration, tissue may be approximated and affixed at various angles. Alternatively,members members - A
top cover 372 which definesopening 374, as shown inFIG. 22A , may be secured over the vacuum chamber inpod member 20. An undercut 358 may be defined around opening 374 to help aid in mechanically adhering any tissue which may be drawn intoopening 374.Opening 374 is shown as being slotted; however, it may be formed into an elliptical shape or various other shapes so long as an adequate opening is available for adhering a sufficient amount of tissue therewithin or thereto. Alternatively, rather than asingle opening 374, multiple smaller openings may be defined overtop cover 372 so long as an adequate area is available for adhering tissue thereto. An optional mesh-like insert may be positioned withinvacuum chamber 340 to help prevent the vacuum chamber from becoming clogged by tissue. - Turning to
FIGS. 24A to 24D, anoptional basket insert 360 is shown in side, end, bottom, and perspective views, respectively.Basket insert 360 may be placed within the vacuum chamber to provide for an optimized mesh surface through which a vacuum force may be applied to the tissue. Overall dimensions of basket insert 360 may vary so long as it may be securely positioned within the vacuum chamber. An example ofinsert 360 dimensions is 1.3 in. (about 3.3 cm) in length and 0.3 in. (about 0.8 cm) in width.Basket insert 360 may also be made from a variety of materials, e.g., stainless steel, provided that the tensile strength is sufficient to withstand the various forces generated. -
Basket insert 360 may havebasket walls 362 forming a mesh-like vacuum chamber 370 withflange 364 surrounding the edges of one open side ofinsert 360. Each of thebasket walls 362 may define a plurality of openings therethrough and the bottom surface ofbasket walls 362 may also define a plurality ofsupports 366 positioned in-betweenopenings 368. These supports 366 may be configured to space each of thebasket walls 362 away from the walls ofvacuum chamber 340, as shown inFIG. 22B , which shows a cross-sectional view of basket insert 360 positioned withinvacuum chamber 340 andtop cover 372 placed over thechamber 340.Plenum 376 may thus be defined around theentire basket insert 360, or a portion thereof, betweenbasket walls 362 andvacuum chamber 340 via the spacing provided bysupports 366 andflange 364. Theopen plenum 376 allows a vacuum force to be applied to the tissue while preventing the tissue from clogging thevacuum chamber 340. - Alternatively, rather than utilizing a
separate basket insert 360 for placement withinvacuum chamber 340, the interior surface ofvacuum chamber 340 may be textured, channeled, labyrinthed, or interdigitated to increase the surface area for vacuum adherence in the same manner asbasket insert 360. Moreover, mechanical tines or teeth may be formed within basket insert 360 or withinvacuum chamber 340 to facilitate additional mechanical adherence of tissue within the pod member. Another alternative may utilize a snare-like wire or member positioned withinvacuum chamber 340 aroundopening 374. In such a variation, once tissue has been drawn throughopening 374, the snare may be drawn tightly around the adhered tissue. - Moreover, one or both pod members may also incorporate a number of other methods to facilitate tissue movement and/or adherence to the respective pod member. For instance,
FIGS. 23A and 23B show thetop cover 372 and cross-sectional view ofbasket insert 360, respectively, ofFIGS. 22A and 22B with the addition ofserrations 341. Theseserrations 341 are shown as being defined along a length ofcover 372; however, they may alternatively be defined around theopening 374 or in a number of various other configurations depending upon the desired results. Furthermore,serrations 341 are illustrated as protrusions but any variations or configurations ofserrations 341 may also be utilized in other variations of the device. - Fixation Assembly
- The fixation assembly, as mentioned above, may be delivered through the main lumen of the folder assembly for deployment over tissue which has been approximated into a folded configuration. One variation of a stapler which may be used with the folder assembly described herein is described in detail in U.S. Pat. No. 4,610,383 (Rothfuss et al.), which is incorporated herein by reference in its entirety. Another variation of a stapler assembly 390, which is positioned at the distal end of the fixation assembly, is shown in side views in
FIGS. 25A and 25B . Generally,stapler cartridge 392 may be pivotally connected via pivot 396 to the end of flexible shaft 398.Anvil 394 may be configured to remain stationary relative to flexible shaft 398 whilestapler cartridge 392 may be manipulatable into an open and closed configuration with respect to flexible shaft 398 andanvil 394. As seen,stapler cartridge 392 and/oranvil 394 may optionally incorporate atapered end 411 positioned at a distal end of eithercartridge 392,anvil 394, or both.Tapered end 411 may be fabricated of any of the polymers or other materials described herein and is preferably atraumatic to facilitate dilation or insertion past tissue. To manipulatestapler cartridge 392 to open and close, a circular or disk-shapedcam 400 may be pivotally attached aboutrotational pivot 402 located on the side of the proximal end ofstapler cartridge 392. As seen in the detail view ofcam 400 inFIG. 26A , actuation wires orcables cam 400 such that whencable 404 is pulled,cam 400 is urged to rotate aboutrotational pivot 402 in the direction ofarrow 408.Actuation cables cam 400 is rotated indirection 408, a portion ofanvil 394 may be engaged bycam 400 thereby forcingstapler cartridge 392 to pivot into an open configuration, as shown inFIG. 25B , whencam 400 is fully rotated, as inFIG. 26B .Cam 400 may be made into other shapes, e.g., oval, elliptical, etc., depending upon the desired design characteristics. Onecam 400 may be utilized, as shown; however, an additional cam may also be affixed on the opposite side ofstapler cartridge 392 such that dual cams are configured to open and close simultaneously in parallel. Alternatively, in the same device, the location ofstapler cartridge 392 andanvil 394 may be reversed (e.g. anvil 394 may be configured to move toward cartridge 392) depending on the location of the desired target and clearance desired. - Detail views of the stapler assembly is shown in
FIGS. 27A to 27D.FIGS. 27A to 27C show cross-sectional side, front, and top views, respectively, ofstapler assembly 410.Cartridge housing 412 generally houses a plurality ofstaples 414 which may be aligned adjacently to one another in one or more rows. The distal ends of bothcartridge housing 412 andanvil 422 may be configured to be atraumatic, e.g., blunted, rounded, etc., to the tissue to be affixed. Moreover,cartridge housing 412 andanvil 422 may be configured such that their cross-sectional shape is keyed to the main lumen of the folder assembly so that the orientation of thecartridge housing 412 is maintained relative to the folder assembly, as described above. -
FIG. 27C shows a top view ofcartridge housing 412 wherein four rows ofstaples 414 may be aligned. Other variations ofcartridge housing 412 may utilize fewer or greater than four rows ofstaples 414. To deploystaples 414 fromcartridge housing 412, twowedges cartridge housing 412 viastaple actuation wire 420.Wedges Staple actuation wire 420 may be manipulated via its proximal end by the user whenstaples 414 are to be deployed out ofcartridge housing 412 into the tissue. -
Staples 414 may be deployed throughstaple apertures 418 defined over the surface ofcartridge housing 412 in apposition tostaple closure surface 424 ofanvil 422. As the staggeredwedges wedge staple apertures 418, as shown inFIG. 27A , and through the tissue until they are engaged incorresponding staple detents 426, as shown inFIG. 27D . As further shown inFIG. 27D , which shows a top view ofstaple closure surface 424 ofanvil 422, eachstaple detent 426 preferably corresponds to the distal ends of each staple 414. - As described above,
cartridge housing 412 and/oranvil 422 may be configured to be atraumatic, e.g., blunted, rounded, etc.; however, it may be desirable to serrate or otherwise roughen the outside edges of both or either thecartridge 412 and/oranvil 422 to ensure full tissue capture upon clamping of the two surfaces. A variation of thestapler assembly 410 is shown inFIG. 28 , which showsserrations 428 defined along the lengths ofcartridge 412 andanvil 422.Serrations 428 may be optionally defined along only one ofcartridge 412 oranvil 422 and it may also be defined only partially along the length. Alternatively, other projections or protrusions, such as spears, may be utilized. In yet another alternative, rather than utilizing projections orserrations 428, the surfaces ofcartridge 412 and/oranvil 422 in contact with the tissue may simply be roughened or sharpened to facilitate serrating or roughening the contacted tissue or may employ absorptive materials in the form of pads, coatings or covers to facilitate traction. Such pads, covers or coatings may be formed of cotton, Goretex®, polyester, Velcro, (see in particular Seamguard™ product (W. L. Gore and Associates, Flagstaff, Ariz.)), etc., and may remain on the surface of the cartridge once staples are delivery, or alternatively may be transmitted with the staples to remain with the tissue affixed thereby. - To facilitate the deployment of the
staples 414 aswedges cartridge housing 412,staple pushers 430 may be utilized. As shown inFIG. 29A , which is a top view of one variation ofstaple pushers 430 positioned overcorresponding staples 414, asingle staple pusher 430 may be configured to engage twostaples 414 in adjacent rows. When a wedge contacts astaple pusher 430, twoadjacent staples 414 may be fired sequentially.FIG. 29B shows a detailed perspective view of one example of astaple pusher 430. In this variation,staple pusher 430 may be comprised of one or more sloped cam surfaces 432, 434 for slidingly engaging a wedge. As a wedge engages a cam surface, it may pushstaple pusher 430 down towardsstaples 414 aspusher 430 is guided via one ormore guides Staple pusher 430 may then engage a first staple viastaple engagement surface 440 and a second staple viastaple engagement surface 442. An example of awedge 446 which may be configured to slide withincartridge housing 412 is shown in the perspective view ofwedge platform 444 inFIG. 29C . Although asingle wedge 446 is shown in the figure extending fromplatform 444, two offset wedges may be configured into a single platform or two individual wedges may be utilized adjacent and offset to one another. - As mentioned above,
cartridge housing 412 may be manipulated into an open and closed position for clamping over the tissue. To control the closure ofcartridge housing 412 againstanvil 422, a stapler control handle may be used, as shown in the cross-sectional views of the stapler control inFIGS. 30A and 30B .FIG. 30A shows stapler handlehousing 450 which may house the tensioning and releasing mechanism for opening andclosing cartridge housing 412 relative toanvil 422.Grip 452 may be provided for the user to grasp while manipulating the device during insertion and deployment as well as to helparticulate actuation handle 454 for opening and/or closingcartridge housing 412. Actuation handle 454 may be pivotally connected tohousing 450 viapivot 458 and to actuation linkage 464 viahandle pivot 460. When actuation handle 454 is pulled towardsgrip 452, handle 454 may rotate aboutpivot 458 and urge actuation linkage 464 to rotate abouthandle pivot 460. The opposite end of actuation linkage 464 may be rotatingly connected viapivot 462 to a translatingslide block 466 contained withinhousing 450. Alternatively, it may be desirable to configure the fixation assembly with the staple jaws preferentially biased in an open position by placing tension onactuation cable 404 with a spring placed in device handle (not shown). Upon insertion of the staple jaws into the main lumen, the jaws may be retained in a closed position by the inner diameter of the main lumen. Upon reaching the yoke portion, the jaws would be adapted to bias open into clearance slots 254 (252) to slide onto either side of presented tissue. Once the fixation has occurred, the jaws of the fixation assembly may be directed to a closed position by the yoke, and then the device main lumen as the fixation assembly is withdrawn from the patient. -
Slide block 466 may anchoractuation cable 404 thereto via a mechanical anchor 470, e.g., crimps, clamps, adhesives, etc. An upper surface ofslide block 466 may compriserack 468 having a plurality of gear teeth defined thereon. When actuation handle 454 is pulled and actuation linkage 464 is urged proximally,slide block 466 may be forced proximally withintravel guide 480, as indicated byarrow 488, to thereby pullactuation cable 404 proximally and thereby forcecam 400 to rotate and open the cartridge housing. Simultaneously, whileslide block 466 is translated proximally,rack 468 may engage andurge gear 484 to rotate clockwise in the figure, which in turn may forcegear 484 to engage andurge rack 474, which is located on a lower surface ofcomplementary slide block 472, to translate distally withintravel guide 478, as indicated byarrow 486. -
Complementary slide block 472 may anchoractuation cable 406 thereto viaanchor 476 in the same or similar manner as anchor 470.Actuation cable 406 may be attached to anchor 476 with aretention spring 482 optionally interposed betweenanchor 476 and slide block 472 to take up any excess slack in thecable 406.FIG. 30B shows the handle assembly after actuation handle 454 has been actuated and slide blocks 466, 472 have been translated within theirrespective channels cartridge housing 412 againstanvil 422 over the tissue. Oncecartridge housing 412 has been clamped over the folded tissue,staple deployment actuator 494 may be rotated or urged to pullstaple actuation wires 420 to fire the staples into the tissue. Once staple deployment has been completed, actuation handle 454 may be urged distally to reverse the process described above to open the clamp for removal from the tissue region or for repositioning the staple assembly in another region of the tissue. - The
actuation cables staple actuation wires 420 may each be routed throughflexible shaft 456, which connects handle 450 tostapler assembly 410.Flexible shaft 456 may be comprised of a tubular member having an outer sheath and an optional inner sheath, either or both of which may be made from any of the polymeric materials described above. Theshaft 456 may further utilize braided materials, e.g., superelastic materials such as Nickel-Titanium alloy, integrated throughout to increase column strength and to prevent kinking. Alternatively,shaft 456 may be formed of wire (round or square flat configuration) to enhance compressive and/or tensile strength. - In a further variation, although the
tissue approximation device 500 may be configured to be flexible, it may also be desirable to actively or passively curve workingbody 502 to assist in overall placement of the system within the target organ for optimal presentation oftissue overlap 100 prior to placement of the stapler assembly, as shown in the perspective views ofFIGS. 31A and 31B . For passive actuation, a curved stylet (not shown) may be placed alongside the actuation rods in the actuation rod channels, or in another available space within the workingbody 502, to bias themain body 502 in the curvature provided by the stylet. Workingbody 502 may be optionally configured to have abending region 504 located proximally of theacquisition assembly 512. Thisoptional bending region 504 may be configured to facilitate bending of a portion of the workingbody 502 in any number of directions or only in a specified direction, depending upon the desired results. - In addition, as depicted in the detail view of
FIG. 31C , adistal position control 507 may be adapted to fit onto workingbody 502 via aconnector tube 514.Distal position control 507 may be further adapted to be integrated into handle 34 (as shown inFIG. 1 ).Distal position control 507 may comprise a base 506, alever 508 configured to rotate aboutpivot 510 located onbase 506, alinkage mechanism 516, anadjustment assembly 518, and acurvature linkage 519. An optional cap or seal 517 may be placed over a proximal end of the base 506 to seal or cover an opening to the main lumen of the working body. In operation,lever 508 may be pivotally mounted tobase 506 vialinkage mechanism 516. Depending on the amount of curvature desired in bendingregion 504,adjustment assembly 518 can be adjusted, e.g., by rotating the mechanism to adjusttension curvature linkage 519 prior to actuation oflever 508.FIG. 31A depicts theassembly 500 in the non-deployed, i.e., a straightened position of workingbody 502, whileFIG. 31B depicts full actuation oflever 508 to impart a curvature to the distal end of workingbody 28. The curvature of bendingregion 504 may accordingly be adjusted to any intermediate position depending upon the degree of actuation oflever 508. Furthermore, although the degree of bending of the distal portion of theassembly 500 relative to a longitudinal axis of workingbody 502 is shown to be about 45° in this example, other variations may be adjusted to have a maximum bend of a lesser or greater degree depending upon the desired bending. Moreover, other variations may allow for bending of theassembly 500 in either a uni-directional manner or in any other direction, again depending upon the desired results. It is further contemplated that the bendingregion 504 may occur at a variety of locations along the shaft of workingbody 502, such as in the distal or proximal region of the working body or at any point therebetween. - As mentioned above, optional cap or seal 517 may be placed over a proximal end of the base 506 to seal or cover an opening to the main lumen of the working body.
FIGS. 32A and 32B show perspective and end views, respectively, of a variation of end cap or seal 517 which may be used to cap the handle ofFIG. 31C .End cap 517 may seal the main lumen yet allow passage of devices through the membrane through a smallexpandable opening 523 covering the main lumen. An optional tab or handle 521 may extend from the cap or seal 517 to facilitate handling of the cover. The cap or seal 517 may be formed from any of the polymeric materials described herein, e.g., silicone. -
FIG. 33 shows a variation 520 of how the tissue approximation assembly may be utilized with other devices such as anendoscope 522. In this example, clearance slots (open region 240) may function to provide clearance for anendoscope 522, or other tool, that can be inserted into and advanced through themain lumen 40 of workingbody 28. Before, during, and/or after tissue approximation,endoscope 522 may be advanced distally out ofmain lumen 40 and advancedpast acquisition assembly 16. A bending region 524 ofendoscope 522 may then be retroflexed to view the results or progress of the tissue approximation and/or fixation using animaging system 526, e.g., optical fibers, CCD or CMOS imaging system, etc., positioned within a distal end of theendoscope 522. -
FIG. 34 shows a portion offlexible shaft 456 of the fixation assembly inserted throughmain lumen 40 ofhandle 110 inassembly 490. Handle 110 is partially shown for clarity. As mentioned above, one orseveral insertion indicators 492 may be defined along a portion offlexible shaft 456 at predetermined positions. These indicators are preferably located near a proximal end ofshaft 456 to indicate information to the user. For instance, whenshaft 456 is aligned againsthandle 110 at one particular indicator, this may notify the user when it is safe forstapler assembly 410 to be opened in a patient body, e.g., whencartridge housing 412 is positioned proximally of the tissue between the yoke members. A second indicator defined alongshaft 456 may indicate to the user when the second indicator is aligned againsthandle 110 that it is safe to clampstapler assembly 410 over the tissue, e.g., whenstapler assembly 410 is positioned fully over the approximated and folded tissue thereby indicating that thecartridge housing 412 may be clamped againstanvil 422 and the tissue for staple deployment. Additional indicators may be defined alongshaft 456 to indicate various other information, e.g., positional information such as how deep stapler assembly has been inserted relative to the folder assembly. These examples are merely intended to be illustrative and are not limiting in how indicators defined along theshaft 456 may be utilized. - Once the tissue has been affixed,
stapler assembly 410 may be removed from the main lumen of the folder assembly and an endoscopic device may be optionally inserted within the main lumen. The endoscopic device may be outfitted with a visual imaging system, e.g., fiberoptic, CCD, CMOS, etc., to view the tissue region. If necessary,stapler assembly 410, or some other tool, may be subsequently inserted through the main lumen to perform additional aspects of the procedure, or to complete the procedure with the placement of additional fixation elements. - In describing the system and its components, certain terms have been used for understanding, brevity, and clarity. They are primarily used for descriptive purposes and are intended to be used broadly and construed in the same manner. Having now described the invention and its method of use, it should be appreciated that reasonable mechanical and operational equivalents would be apparent to those skilled in this art. Those variations are considered to be within the equivalence of the claims appended to the specification.
Claims (40)
1. A tissue acquisition and fixation system comprising:
a tissue acquisition device having an elongate main body defining a main lumen therethrough, a distal end of the acquisition device having a tissue adhering member adapted to acquire tissue from within a hollow body organ, and a tissue tensioning member adapted to tension the acquired tissue; and
a tissue fixation device adapted to be advanced through the main lumen for affixing the acquired tissue.
2. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are in apposition to one another.
3. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are longitudinally positioned relative to one another at a distal end of the main lumen such that the tissue fixation device is stabilized from lateral movement between the at least two opposing members.
4. The system of claim 1 wherein the tissue tensioning member is further adapted to configure the acquired tissue into at least one fold of tissue.
5. The system of claim 1 wherein the tissue fixation device comprises a flexible shaft connected to a cartridge assembly, the flexible shaft having at least one indicator defined thereon for alignment with the tissue acquisition device, wherein a position of the indicator relative to the tissue acquisition device corresponds to a predetermined position of the cartridge assembly relative to the main body.
6. The system of claim 5 wherein the flexible shaft defines at least a second indicator thereon spaced apart relative to the at least one indicator.
7. The system of claim 5 wherein the tissue acquisition device comprises a complementary indicator thereon for corresponding alignment with the at least one indicator, wherein alignment of each indicator is indicative of the cartridge assembly being actuatable.
8. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are each articulatable via a corresponding actuation rod disposed along a length of the main body, wherein each actuation rod is manipulatable via its proximal end.
9. The system of claim 8 wherein each actuation rod further comprises an actuation rod tubing through which each actuation rod is slidably positionable.
10. The system of claim 9 wherein a distal end of each actuation rod tubing is adapted to terminate proximally of a distal end of the actuation rod, wherein each actuation rod tubing is attached near or at a distal end of the main body.
11. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are each individually articulatable from a first delivery configuration to a second expanded configuration.
12. The system of claim 1 wherein the tissue adhering member and the tissue tensioning member are simultaneously articulatable from a first delivery configuration to a second expanded configuration.
13. The system of claim 1 wherein the tissue adhering member defines at least one opening adapted to adhere tissue thereto via a vacuum.
14. The system of claim 13 further comprising at least one vacuum tubing positioned along at least a portion of the main body, wherein the vacuum tubing is adapted to maintain fluid communication through the opening.
15. The system of claim 1 further comprising at least one meshed basket positioned within the tissue adhering member.
16. The system of claim 1 further comprising a first hinge member and a second hinge member each pivotally connecting a corresponding tissue adhering and tissue tensioning member to the main body.
17. The system of claim 16 wherein at least one hinge member is angled relative to its corresponding member.
18. The system of claim 1 further comprising a guidewire for positioning the distal end of the tissue acquisition device.
19. The system of claim 1 wherein the tissue acquisition device further comprises an atraumatic distal tip.
20. The system of claim 19 wherein the atraumatic distal tip is tapered.
21. The system of claim 1 wherein the elongate main body of the tissue acquisition device is configured to be curved.
22. The system of claim 21 wherein the elongate main body is actively or passively curved.
23. The system of claim 22 wherein the elongate main body is passively curvable via a curved stylet removably insertable within the main body.
24. The system of claim 22 wherein the elongate main body is actively curvable via a proximally located position control.
25. The system of claim 1 wherein the elongate main body defines at least one bending region.
26. The system of claim 25 wherein the elongate main body is adapted to be unidirectionally curved.
27. The system of claim 25 wherein the elongate main body is adapted to be curved in a plurality of directions.
28. The system of claim 1 further comprising a handle connected to a proximal end of the main body.
29. The system of claim 28 wherein the handle further comprises at least one actuation mechanism adapted to articulate the distal end of the tissue acquisition device.
30. The system of claim 28 wherein the handle further comprises a gasket adapted to prevent fluid communication through an interior of the handle when the tissue fixation device is positioned therethrough.
31. The system of claim 1 wherein the main body is comprised of a plurality of adjacent links through which the main lumen is defined.
32. The system of claim 31 wherein at least a majority of the links are adapted to pivot with respect to the adjacent link.
33. The system of claim 1 wherein the tissue fixation device comprises a handle connected to a cartridge assembly via a flexible shaft.
34. The system of claim 33 wherein the handle is adapted to articulate the cartridge assembly from a clamped configuration to an open configuration.
35. The system of claim 33 wherein the handle is further adapted to deploy a plurality of staples from the cartridge assembly.
36. The system of claim 33 wherein the cartridge assembly comprises a stapler housing and an anvil in apposition to the stapler housing.
37. The system of claim 36 wherein the stapler housing is adapted to rotate about a pivot relative to the anvil from a clamped configuration to an open configuration.
38. The system of claim 36 further comprising a plurality of staples positionable within the stapler housing.
39. The system of claim 1 wherein the tissue fixation device is adapted to maintain a fixed orientation relative to the main lumen.
40.-52. (canceled)
Priority Applications (1)
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US11/716,157 US8590761B2 (en) | 2004-02-05 | 2007-03-09 | Single fold system for tissue approximation and fixation |
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US8590761B2 (en) | 2013-11-26 |
US7757924B2 (en) | 2010-07-20 |
US20050177176A1 (en) | 2005-08-11 |
US20070112364A1 (en) | 2007-05-17 |
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